Assessing DCog Short for Neurotoxicity in CAR-T

NCT07403812 | Not Yet Recruiting

• 1 other identifier: 25-610
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to determine the effectiveness of DCog Short, a self-reporting, iPad-based application tool, in assessing neurotoxicity in participants undergoing CAR-T cell therapy.

Conditions

Neurotoxicity; Hematologic Malignancy; Neurotoxicity Syndromes; Immune Effector Cell Associated Neurotoxicity Syndrome

Keywords

Neurotoxicity; Neurotoxicity Syndrome; Hematologic Malignancy; Immune Effector Cell Associated Neurotoxicity Syndrome

Outcome Measures

Primary Outcomes (5)

• Sensitivity of DCog Short for Early Detection of Neurotoxicity

  Neurotoxicity is defined as any decrease from 10 on the Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) 10-point scale, where 10 indicates no impairment. The DCog Short assessment will be compared with the standard clinical ICANS evaluation to determine its ability to detect neurotoxicity on or before the onset of clinically confirmed ICANS. Sensitivity is defined as the proportion of patients with clinically confirmed ICANS for whom DCog Short indicates neurotoxicity on or before ICANS onset. DCog Short will be considered effective if sensitivity is ≥75% and non-promising if sensitivity is \<50%.

  Until 30 days post CAR T-cell infusion, with frequency as described in the protocol schedule section 10.0.

• Specificity of DCog Short for Early Detection of Neurotoxicity

  Neurotoxicity is defined as any decrease from 10 on the Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) 10-point scale, where 10 indicates no impairment. The DCog Short assessment will be compared with the standard clinical ICANS evaluation to determine its ability to correctly identify patients who do not develop neurotoxicity. Specificity is defined as the proportion of patients who do not develop clinically confirmed ICANS and are not indicated by DCog Short. DCog Short will be considered effective if specificity is ≥75% and non-promising if specificity is \<50%.

  Until 30 days post CAR T-cell infusion, with frequency as described in the protocol schedule section 10.0.

• Positive Predictive Value (PPV) of DCog Short for Early Detection of Neurotoxicity

  Neurotoxicity is defined as any decrease from 10 on the Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) 10-point scale, where 10 indicates no impairment. The DCog Short assessment will be compared with the standard clinical ICANS evaluation to determine its ability to correctly identify patients who do not develop neurotoxicity. Positive predictive value is defined as the proportion of patients indicated by DCog Short who subsequently develop Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) based on standard clinical assessment.

  Until 30 days post CAR T-cell infusion, with frequency as described in the protocol schedule section 10.0.

• Negative Predictive Value (NPV) of DCog Short for Early Detection of Neurotoxicity

  Neurotoxicity is defined as any decrease from 10 on the Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) 10-point scale, where 10 indicates no impairment. The DCog Short assessment will be compared with the standard clinical ICANS evaluation to determine its ability to correctly identify patients who do not develop neurotoxicity. Negative predictive value is defined as the proportion of patients not indicated by DCog Short who do not develop Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) based on standard clinical assessment.

  Until 30 days post CAR T-cell infusion, with frequency as described in the protocol schedule section 10.0.

• Raw Accuracy of DCog Short for Early Detection of Neurotoxicity

  Neurotoxicity is defined as any decrease from 10 on the Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) 10-point scale, where 10 indicates no impairment. The DCog Short assessment will be compared with the standard clinical ICANS evaluation to determine its ability to correctly identify patients who do not develop neurotoxicity. Raw accuracy is defined as the proportion of patients correctly classified by DCog Short, including both patients who develop Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) and those who do not, based on standard clinical assessment.

  Until 30 days post CAR T-cell infusion, with frequency as described in the protocol schedule section 10.0.

Secondary Outcomes (2)

• Immune Effector Cell-Associated Encephalopathy (CARTOX-10) Score Change from Baseline

  Until 30 days post CAR T-cell infusion, with frequency as described in the protocol schedule section 10.0.

• Differences in Neurotoxicity Development and Detection Across CAR T-Cell Therapy Types

  Until 30 days post CAR T-cell infusion, with frequency as described in the protocol schedule section 10.0.

Study Arms (1)

CAR-T Cell Therapy Patients

EXPERIMENTAL

40 enrolled participants will complete: * Baseline visit * Daily study visits during hospitalization, then via phone: 2x weekly on days 14 - 21, then weekly on days 21 - 30 * 90 Day follow up visit

Behavioral: DCog Short

Interventions

DCog Short BEHAVIORAL

An iPad-based cognitive assessment instrument to evaluate neurotoxicity and consisting of a series of tests that measure various aspects of cognitive function. After hospital discharge, participants will be provided with iPads which will be returned at the 90 day follow up visit.

CAR-T Cell Therapy Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• participants treated with CART-Cell therapy as described above and therefore at risk for treatment associated neurotoxicity.
• Visual acuity of 20/100 or better.

You may not qualify if:

• patients \< 18 years old
• pregnant women
• prisoners
• adults unable to consent,
• participants unwilling to use iPad-based tools. Severe motor deficits that can prevent patients from using an iPad

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Neurotoxicity Syndromes; Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Nervous System Diseases; Poisoning; Chemically-Induced Disorders; Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Jon Arnason, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jon Arnason, MD

CONTACT

(617) 667-9920; jarnason@bidmc.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 4, 2026
• First Posted: February 11, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2027
• Last Updated: February 11, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Beth Israel Deaconess Medical Center Technology Ventures Office at tvo@bidmc.harvard.edu

Locations

US (1)